the clinical outcome camparison between covered …...the clinical outcome camparison between...
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![Page 1: The clinical outcome camparison between covered …...The clinical outcome camparison between covered stent(CV) and drug-eluting balloon(DEB) for SFA lesions: a single center result](https://reader034.vdocument.in/reader034/viewer/2022050207/5f5a5ef2246d4f30d51597f1/html5/thumbnails/1.jpg)
The clinical outcome camparison between covered
stent(CV) and drug-eluting balloon(DEB) for SFA lesions:
a single center result
Li Ming MD
Associated Professor in Vascular Surgery
2nd Xiangya Hospital, CSU
Provincial Center of Major Vessel Disease in Hunan
Vascular Surgery Center of CSU
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Disclosure
Speaker name:
..Li Ming...............................................................................
I have the following potential conflicts of interest to report:
Consulting
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
R I do not have any potential conflict of interest
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Background
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Background
Viabahn for femoropopliteal in-stent restenosis. Al Shammeri O, Bitar F, Ghitelman J,
Soukas PA. Ann Saudi Med. 2012 Nov-Dec;32(6):572-82.
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Background
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Method
From 2015.6 to 2017.6, 53 patients’ data were reviewed
CS group: 32 pts, DEB group: 21pts
Inclusion criteria:
Rutherford 2-5
DE novo or ISR
SFA occlusive lesions >10cm
Post-op management: Clopidogrel 75mg +Aspirin 100mg
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Baseline Characteristics
Characteristics CS group (n=32) DEB group(n=21) P Value
Age 65.66±12.35 64.05±12.81 1.000
Male 28(87.5%) 18(85.7%) 0.8510
Smoker 25(78.1%) 16(76.2%) 0.8693
Hypertension 13(40.6%) 10(47.6%) 0.6153
Hyperlipidemia 18(56.2%) 11(52.3%) 0.7820
CHD 12(37.5%) 8(38.1%) 0.9651
Diabetes 10(31.3%) 7(33.3%) 0.8737
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Clinical Data
Characteristics CS group (n=32) DEB group(n=21) P Value
Rutherford 2 6(18.8%) 7(33.3%) 0.2275
Rutherford 3 13(40.6%) 6(28.6%) 0.3708
Rutherford 4 7(21.9%) 4(19.0%) 0.8039
Rutherford 5 6(18.8%) 4(19.0%) 0.9784
ISR 12(37.6%) 8(38.0%) 0.9651
Length of treated vessel(mm,Average)
285.9 233.3 P<0.01
Diameter of treatedvessel(mm,Average)
5.13 5.24 0.4796
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Peri-operative Complications
Complications CS group (n=32) DEB group(n=21) P Value
MI 1 1 0.7597
Stroke 0 0
Renal failure 2 1 0.8187
Infection 0 0
Distal embolism 0 1 0.2127
Hematoma 0 0
Pseudoaneurysm 0 0
Overall death 1 0 0.4134
Procedure related death
0 0
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Results
Complications CS group (n=32) DEB group(n=21) P Value
Amputation 0 0
Overall death 2(6.3%) 1(4.8%) 0.8187
Operation related death
0 0
Primary Patency@1 year
16(50%) 13(61.9%) 0.4673
Secondary Patency@1 year
26(81.2%) 18(85.7%) 0.6720
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Results(ISR subgroup)
Complications CS group (n=12) DEB group(n=8) P Value
Mean length(mm) 254.8 184.0 P<0.01
Mean Diameter(mm) 5.17 5.19 0.9252
Amputation 0 0
Overall death 0 0
Operation related death
0 0
Patency rate(@6 months)
83.3% 87.5% 1.0
Patency rate(@12 months)
58.3% 75% 0.4439
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Discussion
Author Year 1 2 3 4
Lammer 2000 Radiology, 217:95-104 80 13.8 NR 79
Jahnke 2003 J Vasc Interv Radiol, 14:41-51 52 8.5 83 78 74 62
Bleyn 2004 Edizioni Minerva Medica, 14:87-91 67 14.3 100 82 73 68 54
Panetta 2005 Endovasc Today, August 41 30.4 90 86 77
Chopra 2006 AIM Symposium, November 13-16 70 20 71 93 87 72
Coats 2006 Endovasc Today, September 83 NR 47 89
Fischer 2006 J Endovasc Ther, 12:281-16 59 10.7 87 67 58 57 52
Zander 2006 SIR Meeting, April 3 31 16.6 NR 86 78 78 78
Saxon 2007 J Vasc Interv Radiol, 18:1341-1350 87 14.2 42 76 65 60 55
Alimi 2008 Eur J Vasc Endovasc Surg, 35:346-352 102 11.7 NR 74 71 71
Djelmami-Hani 2008 SCAI Meeting, March 29 - April 1 132 21 39 80
Saxon 2008 J Vasc Interv Radiol, 18:823-832 97 7 21 65
VIBRANT 2009 VIVA, September 19-22 72 19 60 53
Kougias 2009 Am J Surgery, 198:645-649 31 23 100 75
Farraj 2009 J Invasive Cardiol, 21:278-281 32 15.4 100 80
Rabellino 2009 Cath Cardiovasc Interv, 73:701-705 32 NR NR 82 75 75 75
McQuade 2010 J Vasc Surg;in press 50 25.6 NR 72 63 63 59
Average / Total 1103 16.2 62 78 72 67 59
NR = Not Reported
Reported patency rates of GORE VIABAHN® Endoprosthesis / GORE HEMOBAHN
Endoprosthesis (5-8mm) treating the SFA in Studies of at least 30 limbs (updated 20-Jul-10)
Primary Patency
(years / %)No. of
Limbs
%
Occlusions
Lesion
Length
(cm)Journal Publication / Presentation
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Discussion
Study name DEB name/manufacturer
Mean lesion length(mm)
POBA DEB
Patency rate(12 months)
DEB POBALEVANT 2 Lutonix 63.2 62.7 65.2% 52.6%
IN. Pact SFA IN.PACT 89.4 88.1 82.2% 52.4%
BIOLUX PI Passeo-Lux 51.4 68.5 84% 47.1%
Acocath AcoTec 152 147 76.1% 33.7%
ILLUMENATE Pivotal Study
Stellarex 80 89 82.3% 70.9%
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Discussion
Our 12 months patency rate of CS andDEB are 50% and 61.9% respectively, bothare lower than literature
Probably due to longer lesion length andhigh percentage of CTO lesion
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Discussion
Complications CS group (n=32) DEB group(n=21) P Value
Stop medicationrate
3(9.4%) 6(28.6%) 0.1315
Modified patency rate
55.2% 76.7% 0.066
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Discussion-ISR subgroup
Complications CS group (n=12) DEB group(n=8) P Value
Mean length(mm) 254.8 184.0 P<0.01
Mean Diameter(mm) 5.17 5.19 0.9252
Patency rate(@6 months)
83.3% 87.5% 1.0
Patency rate(@12 months)
58.3% 75% 0.4439
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Discussion-ISR subgroup
The Treatment of Superficial Femoral Artery In-Stent Restenosis:
The Jury Is Still Out. Gray BH et al. JACC Cardiovasc Interv. (2016)
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Discussion-ISR subgroup
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Conclusion
Real world experience comparing CS and DEB
DEB showed advantage over covered stent in treating SFA long lesion
Covered stent still plays a role in PAD treatment, especially for ISR
More data and longer follow-up time is needed
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Thank you for your attention!
谢谢!
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The clinical outcome camparison between covered
stent(CV) and drug-eluting balloon(DEB) for SFA lesions:
a single center result
Li Ming MD
Associated Professor in Vascular Surgery
2nd Xiangya Hospital, CSU
Provincial Center of Major Vessel Disease in Hunan
Vascular Surgery Center of CSU